Schell C.A.P.P. Bed Model Nrs. 1268 + 1269
FDA 510(k) K871368 · Schell B.V.
510(k) numberK871368
Submission
- Device name
- Schell C.A.P.P. Bed Model Nrs. 1268 + 1269
- Applicant
- Schell B.V.
Aa Belfeld, NL - Received
- April 7, 1987
- Decision date
- May 1, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOQ – Bed, Flotation Therapy, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5170
- Specialty
- Physical Medicine
Other 510(k)s with product code IOQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | Hill-Rom | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | Hill-Rom | 06/03/2013SE |
| K973624 | Nurse's Aid Patient Rotation SystemIOQ · Traditional | Air Med Assist Products | 01/21/1998SE |
| K970364 | AIRTEC2 Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970363 | Hydrotec Low Air Loss Therapy BedIOQ · Traditional | Apex Metal, Inc. | 11/17/1997SE |
| K970636 | Totalcare., Modular Therapy System (MTS)IOQ · Traditional | Hill-Rom, Inc. | 08/26/1997SE |
| K964873 | Silkair Low Airloss TherapyIOQ · Traditional | Hill-Rom, Inc. | 07/03/1997SE |
| K970295 | Flexicair Exlipse PlusIOQ · Traditional | Hill-Rom, Inc. | 05/16/1997SE |
| K943433 | Total Contact Seat Ripple SystemIOQ · Traditional | Numotech, Inc. | 07/31/1995SE |
| K951001 | Flexicair ExlipseIOQ · Traditional | Hill-Rom, Inc. | 06/27/1995SE |
Questions and answers
When was Schell C.A.P.P. Bed Model Nrs. 1268 + 1269 cleared by the FDA?
Schell C.A.P.P. Bed Model Nrs. 1268 + 1269 (K871368) received a 510(k) decision of Substantially Equivalent on May 1, 1987, 24 days after the submission was received.
What is the product code of K871368?
The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.